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AVB-S6-500/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)

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ClinicalTrials.gov Identifier: NCT04729608
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : September 27, 2021
Sponsor:
Collaborators:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Aravive, Inc.

Brief Summary:
This is a randomize, double-blind Phase 3 study to compare the efficacy and safety of AVB-S6-500 in combination with paclitaxel (Pac) versus placebo in combination with Pac in patients with platinum resistant recurrent ovarian cancer.

Condition or disease Intervention/treatment Phase
Platinum-resistant Ovarian Cancer Drug: AVB-S6-500 Drug: Paclitaxel Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-S6-500 in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)
Actual Study Start Date : April 22, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: AVB-S6-500+Pac
Combination of AVB-S6-500 and Pac
Drug: AVB-S6-500
AVB-S6-500 is an experimental drug

Drug: Paclitaxel
Paclitaxel is the standard of care, background therapy
Other Name: Taxol

Placebo Comparator: Placebo+Pac
Placebo-controlled arm with Pac
Drug: Paclitaxel
Paclitaxel is the standard of care, background therapy
Other Name: Taxol

Other: Placebo
Matching placebo




Primary Outcome Measures :
  1. Anti-tumor activity of AVB-S6-500 in combination with Pac measured by progression free survival (PFS) in patients receiving AVB-S6-500+ Pac versus patients receiving Placebo+Pac [ Time Frame: 4 months ]
    PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 20 months ]
    Time following the treatment until death


Other Outcome Measures:
  1. Duration of response (DOR) [ Time Frame: 9 months ]
    Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

  2. Objective response rate (ORR) [ Time Frame: 3 months ]
    Proportion of subjects who have a confirmed partial or complete response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria

  3. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 10 months ]
  4. Quality of Life (QOL) [ Time Frame: 10 months ]
    Subject QOL will be assessed using the Functional Assessment Of Cancer Therapy - Ovarian Cancer (FACT-O) questionnaire, which consists of 4 subscales: physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), and functional well-being (7 questions), and 12 additional concerns specific to ovarian cancer. All items are rated on a 5 point scale with 0 "not at all" and 4 "very much". The scoring algorithm allows for eight summary scales: the four core well-being subscales, a subtotal of the 27 core items, a subtotal of the 12 ovarian-specific additional concerns, a grand total of the 39 items, and a trial outcome index (sum of the 17 physical and functional wellbeing items plus the 12 ovarian-specific items).

  5. Clinical benefit rate (CBR) [ Time Frame: 4 months ]
  6. Area under the AVB-S6-500 concentration-time curve. [ Time Frame: 10 months ]
  7. Maximum observed AVB-S6-500 concentration. [ Time Frame: 10 months ]
  8. Minimum observed AVB-S6-500 concentration. [ Time Frame: 10 months ]
  9. Pharmacodynamic marker assessment [ Time Frame: 10 months ]
    Change from the baseline in GAS6 serum levels.

  10. Anti-drug antibody (ADA) titers [ Time Frame: 10 months ]
  11. Cancer antigen 125 (CA-125) levels [ Time Frame: 10 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
  • Aged 18 years or older
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
  • Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance.
  • Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
  • Received at least 1 but not more than 4 prior therapy regimens.

Note: Maintenance therapy OR hormonal therapies should not be counted as a separate therapy.

Note: Patients who have not received prior bevacizumab must be deemed medically inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.

  • Measurable disease according to RECIST v1.1 criteria
  • Normal gastrointestinal function.
  • At least 28 days between termination of prior anticancer or hormonal therapy and first administration of AVB-S6-500.
  • Full recovery from all treatment-related toxicities to Grade 1 or less, except alopecia.

Exclusion Criteria:

  • Tumors in the breast or bone
  • Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on >10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
  • Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen)
  • Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
  • Received prior therapy with PAC in the platinum-resistant recurrent setting
  • Evidence of clinically significant third spacing (e.g., pleural effusions, ascites, anasarca, etc.) that requires therapeutic intervention within 28 days prior to first dose of AVB-S6-500/placebo

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729608


Contacts
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Contact: Aravive Clinical Trials 936-355-1910 clinicaltrials@aravive.com

Locations
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Sponsors and Collaborators
Aravive, Inc.
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
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Study Director: Eduardo Pennella, MD Aravive, Inc.
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Responsible Party: Aravive, Inc.
ClinicalTrials.gov Identifier: NCT04729608    
Other Study ID Numbers: AVB500-OC-004
GOG-3059 ( Other Identifier: GOG Foundation )
ENGOT OV66 ( Other Identifier: ENGOT )
AXLerate-OC ( Other Identifier: Aravive )
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aravive, Inc.:
Ovarian cancer
Platinum resistant
Recurrent ovarian cancer
High-grade serous adenocarcinoma
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action